October 21, 1999 

VETERINARY SERVICES MEMORANDUM NO. 800.66 

Subject: Freedom of Information Act Requests Involving 

 Veterinary Biological Products 

To: Biologics Licensees, Permittees, and Applicants 

 Directors, Center for Veterinary Biologics 

I. PURPOSE 

This memorandum provides guidelines concerning Animal and Plant Health Inspection 

Service (APHIS) implementation of the Freedom of Information Act (FOIA) as it applies 

to materials submitted to the Center for Veterinary Biologics (CVB) by manufacturers of 

veterinary biological products. 

II. CANCELLATION 

This memorandum cancels Veterinary Services Memorandum No. 800.66 dated May 7, 

1985. 

II. BACKGROUND

APHIS receives requests under the FOIA for materials that are submitted to CVB by 

manufacturers of veterinary biological products in support of applications for licenses, 

permits, and product revisions. In many instances, the submitters (manufacturers) do not 

want some of these materials to be disseminated because they consider them to be 

confidential. 

Under the terms of the FOIA, as interpreted by the courts, APHIS has the sole 

responsibility for determining whether the material is confidential within the meaning of 

the FOIA. The courts have determined that information submitted to the Government is 

confidential if its release would be likely either: (1) to impair the Government’s ability to 

obtain necessary information in the future or (2) to cause substantial competitive harm to 

the submitter. 

If a manufacturer would like APHIS to protect information from disclosure, each 

submission containing information to be protected must be accompanied by a statement 

indicating specific reasons why release of the information is likely to cause substantial 

harm to the competitive position of the submitter. 
Veterinary Services Memorandum No. 800.66 2 

III. GUIDELINES

A. Confidentiality Statements from the Manufacturer

The burden placed on the Government to sustain withholding of information is high. 

Therefore, the manufacturer’s accompanying reasons for withholding information should 

directly specify how release of a particular piece of information would be likely to 

substantially harm a competitive position. Mere conclusive statements have consistently 

been held to be insufficient to satisfy the Government’s burden. 

1. Content of Confidentiality Statements - Confidentiality statements 

should be specific and complete. 

 

a. Specify the parts, sections, paragraphs, lines, or words in each 

document the manufacturer considers confidential. 

b. Include the reasons that disclosure of the specified information 

would cause substantial harm to the competitive position of the 

manufacturer. 

2. Presentation of Confidentiality Statements - Manufacturers should 

provide confidentiality statements with Outlines of Production, outline page 

revisions, labels, facilities documents, protocols, data, and other materials that 

they consider confidential as follows: 

a. Include the statement in Section VI. E. of new and completely 

revised Outlines of Production. 

b. Add the statement to the summary of changes page when 

submitting outline page revisions. 

c. Include the statement in the body of protocols, data 

submissions, production and test reports, comments on program directives, 

and facilities documents. 

d. Include the statement on mounting sheets for label sketches and 

prelicense labels. 

B. APHIS Processing

APHIS will process requests for information concerning veterinary biological products 

under the FOIA as follows: 

1. The APHIS FOIA Coordinator will review all the information related 

to the request for confidentiality. 
Veterinary Services Memorandum No. 800.66 3 

2. Disclosure of information related to the request for confidentiality will 

be made only after consultation with the licensee, permittee, or applicant. 

 /s/ Thomas E. Walton for

Alfonso Torres 

Deputy Administrator 

Veterinary Services